Alder Biopharmaceuticals, Inc.

Associate Director, Statistical Programming

Alder is revolutionizing the way antibody therapies are identified, selected, developed and produced. Our proprietary technologies make great strides possible in the field of antibody therapeutics, yielding innovative potential new treatments for conditions such as migraine and rheumatoid arthritis.

Reports to: Associate Director, Statistical Programming

Job Description

The Associate Director of Statistical Programming will be responsible for leadership of statistical programming that supports multiple drug development programs. The position requires a broad, comprehensive and detailed knowledge of statistical programming languages and software, filing support, clinical trial databases, and pharmaceutical drug development processes. The incumbent will assist the head of Statistical Programming to develop, recommend, and implement standard procedures, measures of performance, and training programs. Role will also serve as Principle Analyst on programs to organize and allocate resources according to multi-project requirements and deadlines and provide leadership to the company in the area of technical expertise.

Specific responsibilities will include:

Act as principle analyst to provide statistical programming service to multiple therapeutic areas.

Provide review and supervision of the assigned resources in a manner that promotes problem solving, career development, and motivation.

Support the Head of Statistical Programming to achieve the company’s goals.

Stay abreast of current regulatory environment focusing on submission standards.

Develop and maintain good communications and working relationships with internal/external functions.

Ensure that the company business needs and partner organizations are satisfied within agreed-upon timelines with respect to statistical programming activities and the exchange of data sets for clinical studies.

Lead the effort of programming process improvement.

Assist in validating software products used by the Statistical Programming department.

Qualifications:

A B.S. (or higher) in Statistics, Computer Science or other closely related field to programming with minimum 10 years of relevant pharmaceutical/biotech industry experience.

At least 2years of demonstrated leadership experience including minimum 3 years in people management; career progression.

Direct experience in leading programming in supporting NDA, BLA and EMEA filings.

Expert experience using industry standards such as CDASH, SDTM, and ADaM.

Experience in development and implementation of statistical programming standards and procedures is required; knowledge of software systems development is required.

In depth understanding of clinical trial principles and regulatory requirements.

Expert knowledge of industry data standards.

Demonstrated ability to manage and lead projects for Statistical Programming.

Effective verbal and written communication and strong interpersonal skills.

Strong project management skills; flexible to changing priorities, detail-oriented, works well under pressure with initiative to take on unfamiliar tasks. Must work well within a dynamic, interdisciplinary, small company environment requiring multi-tasking and changing priorities.